Pharmaceutical & BioTech

The advertising of medicinal products is defined at a European level in European pharmaceutical laws.

The actual control of the promotion of medicinal products operates at a national level. In some countries like Italy and France a pre-approval by Authorities (AIFA, ANSM) is required prior to the use of promotional materials.
In addition, the European Federation of Pharmaceutical Industries Association (EFPIA) (http://www.efpia.eu/) has adopted the EFPIA Code of Practice, covering the promotion of medicinal products to healthcare professionals and interactions with healthcare professionals and patient organizations.

RPN offers a wide range of services related to the review of institutional, disease awareness, and promotional materials for compliance with local requirements in the different European markets.

Our flexible solutions include customized regulatory and technical support. RPN is a pioneer in exploring innovative promotional solutions and approaches (e.g., omnichannel and digital campaigns), providing valuable advice to stay competitive in the ever-changing regulatory and promotion landscape.

RPN solutions include:

• Regulatory and medical review, validation, and submission (if required) of institutional, disease awareness, and promotional materials for the European markets.
• Regulatory review of congress sponsorship initiatives, including compliance with applicable European (e.g., EFPIA) and local industry codes, and management of congress sponsorship authorizations with local authorities where applicable.
• Support in establishing, training, and validating procedures, including writing or reviewing Standard Operating Procedures (SOPs) and working instructions at the local level.
• Guidance on software workflows tailored to each market, considering local requirements for the review, approval, and signature of promotional items. We manage the review and validation of promotional materials in local languages and within client systems such as VEEVA®, Trackwise®, and others.
• Training on promotional material review and validation requirements for local needs.
• Regulatory support for sales reps’ activities.
• A global network of local partners who can serve as local signatories or responsible persons according to local requirements.